BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG CLEAR PFE PUURS

    MDR report key: 10686929 · Received October 15, 2020

    Report

    Report Number
    3009081593-2020-00118
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 22, 2020
    Report Date
    October 7, 2020
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K011369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PMA/510(K)#: AN ADDITIONAL PMA/510(K) IS LISTED AS K122558. (B)(4). INVESTIGATION: NEITHER SAMPLE NOR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), AND WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ULTRASAFE X100L PNG CLEAR PFE PUURS EXPERIENCED THE SPRING FORCE ACTIVATION BEING TOO STRONG FOR THE END USER PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER OBSERVED VARIATIONS OF THE ACTIVATION FORCE DURING THEIR CONTROL TESTS AT THE END OF THE PRODUCT ASSEMBLY AT THEIR MANUFACTURING SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152724 ULTRASAFE X100L PNG CLEAR PFE PUURS PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 7102027

    Patients

    Seq Age Sex Outcome Treatment
    1 Other